Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI

Myocardial Infarction Clinical Trial

Official title:

A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intravenous ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With st Elevated Acute Myocardial Infarction (Stemi)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883727
• Other study ID #: SRPL/AMI/07-08/001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 17, 2009
• Last updated: March 4, 2013
• Start date: April 2009
• Est. completion date: August 2012

Study information

• Verified date: March 2013
• Source: Stempeutics Research Pvt Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2012
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with STEMI aged between 20 and 70 years, either males or females with non-child bearing potential, after 2 days of successful PCI.

• Patient has global left ventricular systolic dysfunction with an ejection fraction of <50% and >30%.

• ECG with sign of acute anterior MI with ST-elevation = 2 mm in at least 2 of the following leads I, AVL, V1-V6, or ECG with sign of acute inferoposterior MI with ST-elevation =1 mm on all of the following leads- II, III, V5-V6 or STelevation = 2 mm in at least 2 of the leads.

• The target lesion located in the proximal section of the left anterior descending, left circumflex or right coronary artery.

• Patient with acute myocardial infarction within 10 days prior to IP administration.

• Normal liver and renal function.

• Able to understand study information provided to him.

• Able to give voluntary written consent.

Exclusion Criteria:

• History of acute/chronic inflammatory condition or severe aortic stenosis or insufficiency; severe mitral stenosis or severe mitral insufficiency.

• Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.

• Advanced renal dysfunction and creatinine = 2mg%.

• Advanced hepatic dysfunction.

• Have clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Stem cell
IV infusion of stem cells
• Plasmalyte A
IV infusion

Locations

Country	Name	City	State
India	SAL Hospital and Medical Institute	Ahmedabad	Gujarat
India	Bhagawan Mahaveer Jain Heart Centre	Bangalore	Karnataka
India	MS Ramaiah Memorial Hospital	Bangalore	Karnataka
India	Care Hospital	Hyderabad	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Stempeutics Research Pvt Ltd

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AE and ECG parameters		6 months	Yes
Secondary	Regional myocardial perfusion and infarct size		6 months	No